A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms (RAPID-III)

April 23, 2025 updated by: Rivermark Medical

A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Not yet recruiting
        • South Coast Urology
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Michael G Oefelein Clinical Trials
      • Beverly Hills, California, United States, 90048
        • Recruiting
        • Comprehensive Urology Medical Group
      • La Mesa, California, United States, 91942
        • Recruiting
        • Atlas Men's Health
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Urology Group of Southern California
      • Tustin, California, United States, 92780
        • Recruiting
        • Prestige Medical Group
    • Colorado
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Urology Denver
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Advanced Urology Institute
    • Illinois
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Duly Health
      • Maywood, Illinois, United States, 60153
        • Not yet recruiting
        • Loyola Medicine
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Southern Urology
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Sheldon Freedman Urology
    • New York
      • New York City, New York, United States, 10016
        • Recruiting
        • Manhattan Medical Research NYU Langone
      • Syosset, New York, United States, 11791
        • Not yet recruiting
        • Northwell Health
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Associated Urologists of North Carolina
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Conrad Pearson Clinic
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Midtown Urology Associates
      • Austin, Texas, United States, 78759
        • Recruiting
        • Urology Austin/Urology America
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male subjects > 45 years of age who have symptomatic BPH
  • International Prostate Symptom Score (IPSS) score >13
  • Peak urinary flow rate (Qmax): >5 mL/sec and <13 mL/sec with minimum voided volume of >125 mL
  • Post-void residual (PVR) <250 mL
  • Prostate volume 25 to 80 mL
  • Prostatic urethral length 20-50 mm
  • Able to complete the study protocol and visits

Exclusion Criteria:

  • Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
  • Prior minimally invasive intervention or surgical intervention of the prostate or urethra
  • PSA >10 ng/mL
  • Bladder cancer or bladder stones
  • Active urinary tract infection (UTI)
  • Uncontrolled diabetes
  • Part of a vulnerable population (cognitively challenged or are incarcerated)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment - FloStent
Flexible cystoscopy procedure with FloStent implant deployed
Device: FloStent
Flexible cystoscopy to deploy medical device used to treat BPH
Sham Comparator: Sham Control
Flexible cystoscopy procedure without FloStent implant deployed
Device: Sham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)
Time Frame: 12 months

The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL).

The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35):

0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent responders to IPSS
Time Frame: 3 months
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
3 months
Percent responders to IPSS
Time Frame: 6 months
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
6 months
Percent responders to IPSS
Time Frame: 12 months
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rivermark Medical

Investigators

  • Study Director: Study Director, MD, Rivermark Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C0002 Rev. 07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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